A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC

Official Title ICMJE

A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC

Brief Summary

To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.

Detailed Description

Not Provided

Study Type ICMJE

Interventional

Study Phase

Not Provided

Study Design ICMJE

Primary Purpose: Treatment

Condition ICMJE

HIV Infections

Intervention ICMJE

Drug: Zidovudine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ICMJE

Inclusion Criteria

Concurrent Treatment:

Allowed:

Electron beam therapy to an area of less than 100 cm2.

Patients with the following are excluded:

Any immediately life-threatening infection or medical condition present at the time of study entry.

Any active opportunistic or other infection requiring chronic therapy present at the time of study entry.

Patients with Pneumocystis carinii pneumonia (PCP) may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 degrees C for at least 48 hours; oxygen (on room air)

- History of Pneumocystis carinii pneumonia (PCP) with histologic verification within 4 months of study entry.

OR History of other opportunistic infection included in the CDC surveillance definition of AIDS (stage IV-C-1), diagnosed within 4 months of entry, but not requiring chronic suppressive therapy, and a CD4+ cell count < 200 cells/mm3.

OR AIDS related complex (ARC) only those patients with a CD4+ count < 200 cells/mm3 and documentation of at least two signs or symptoms from the list below. One sign or symptom must be weight loss or candidiasis as described.

Negative Venereal Disease Research Laboratory (VDRL) or Rapid Plasma Reagent (RPR) or, if positive and verified by Fluorescent Treponemal Antibody Absorption (FTAABS), documented history of treatment for syphilis. If FTAABS is positive, but treatment history is not available, the patient may be entered 3 or more days following the initiation of appropriate chemotherapy.